Amiodarone, Lidocaine or Neither for Out-Of-Hospital Cardiac Arrest Due to Ventricular Fibrillation or Tachycardia

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the trial is to determine if survival to hospital discharge is improved with early therapeutic administration of a new Captisol-Enabled formulation of IV amiodarone (Nexterone-PM101) compared to placebo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborators: American Heart Association; Canadian Institutes of Health Research (CIHR); Defence Research and Development Canada; Heart and Stroke Foundation of Canada; National Heart, Lung, and Blood Institute (NHLBI); U.S. Army Medical Research and Development Command; U.S. Army Medical Research and Materiel Command
• Treatments: Amiodarone; Lidocaine

Criteria

Inclusion Criteria:

• Age at least 18 years or local age of consent

• Non-traumatic out-of-hospital cardiac arrest treated by Resuscitation Outcomes Consortium (ROC) emergency medical services (EMS) with advanced life support capability

• VF or pulseless VT presenting as the initial arrest arrhythmia or results from conversion of another arrhythmia (such as transient asystole or pulseless electrical activity)

• Incessant or recurrent VF/VT after receipt of ≥ 1 shocks

• Established vascular access

Exclusion Criteria:

• Asystole or pulseless electrical activity (PEA) as the initial arrest rhythm who never transition to VF or pulseless VT

• Written advance directive to not attempt resuscitation (DNAR)

• Blunt, penetrating, or burn-related injury

• Exsanguination

• Protected populations (prisoners, pregnancy, children under local age of consent)

• Treated exclusively by non-ROC EMS agency/provider, or by basic life support-only capable ROC EMS providers

• Prior receipt of open label lidocaine or amiodarone during resuscitation